(190 days)
Orthopedic, arthroscopic, spinal, and neurosurgical
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatop!asty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
The SurgiMax / SurgiMax Plus is a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device can be used with monopolar or bipolar devices. The energy is used for cutting, coagulation, and hemostasis.
The SurgiMax / SurgiMax Plus Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status.
Power level for each mode is indicated by front panel digital displays; which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.
This device is designed to comply with international safety standards including applicable IEC series electrical safety standards.
The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions including short and open for monopolar mode.
Three output waveforms are provided:
CW CUT - Continuous wave output with average power equal to the maximum with no deliberate modulation.
CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 75 Hz rate.
HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 75 Hz rate.
The provided 510(k) summary for the Elliquence SurgiMax / SurgiMax Plus electrosurgical unit does not contain the information requested in your prompt regarding acceptance criteria and a detailed study proving performance.
This document is a marketing submission to the FDA demonstrating "substantial equivalence" to a predicate device, not a report of an original clinical or performance study with acceptance criteria.
Here's a breakdown of why the requested information is absent and what is provided:
1. A table of acceptance criteria and the reported device performance
- Absent. The document does not define specific acceptance criteria for performance such as accuracy, sensitivity, or specificity, as it's not a diagnostic device. For an electrosurgical unit, performance is typically measured by output power, frequency, and waveform consistency. These specifications are provided in a table within the document (see "Output Characteristics:") but without explicit acceptance criteria or a formal performance study against them. Instead, it states the device "complies with IEC 60601-2-2."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Absent. No test set or associated data is described. The submission relies on "non-clinical testing and comparison between the subject device and predicate device" to demonstrate equivalent performance, which generally involves engineering bench testing rather than a clinical "test set" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Absent. Since there is no described test set involving patient data, there would be no ground truth established by medical experts for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Absent. No test set necessitating adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Absent. This device is an electrosurgical unit, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Absent. Again, this is an electrosurgical unit, not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Absent. No "ground truth" for diagnostic purposes is relevant to this device. Performance is instead confirmed through engineering compliance and comparison to the predicate device's specifications.
8. The sample size for the training set
- Not applicable/Absent. This is not an AI/machine learning device, so there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable/Absent. As above, no training set.
What the document does provide regarding performance and equivalence:
- Predicate Device Comparison: The core of this 510(k) submission is to demonstrate "substantial equivalence" to a previously cleared device, the Ellman SurgiMax (K061174). The document explicitly states: "The subject device and predicate device have identical indications for use, waveforms, functionality with bipolar and monopolar devices, frequency, maximum power, weight, and power adjustment. The electronics and software in the subject device is the same identical electronics and software in the predicate device. The outputs and performance characteristics are identical as the electronics and software have not changed."
- Compliance with Standards: It states that the "Ellman SurgiMax / SurgiMax Plus complies with IEC 60601-2-2." This international standard specifies general requirements for basic safety and essential performance of electrosurgical equipment. Compliance with such a standard serves as a key piece of performance evidence for this type of device.
- Non-Clinical Testing: The document vaguely mentions "Non-clinical testing and comparison between the subject device and predicate device demonstrate equivalent performance." This typically refers to bench testing of electrical outputs, power delivery, safety features, etc., against the device's own specifications and the predicate's known performance, but no details of these tests (e.g., sample sizes, specific measurements, acceptance criteria) are provided in this summary.
In summary, for a device like an electrosurgical unit seeking 510(k) clearance, the "study" demonstrating it meets acceptance criteria often involves compliance with applicable recognized standards and benchtop engineering testing to prove that its specifications (like power output, frequency, and waveform) match those of a legally marketed predicate device, rather than a clinical study with patients and expert-adjudicated ground truth.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.